Postoperative InfectionNCT06612177
Elderly Patients Surgical Site Infection Phenotypes Identification
An observational study of Postoperative Infection and Geriatrics, run by Weidong Mi at 1 site in China.
Trial summary
This study utilizes Latent Class Analysis (LCA) to identify phenotypes of Surgical Site Infection (SSI) in elderly patients following non-cardiac surgery. By analyzing data from two large cohorts, the research establishes a predictive model that uncovers independent risk factors for SSI, including age, hyperlipidemia… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Infection, Geriatrics, Prediction
- How many people
- 42,532 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The Training set included 42,532 elderly patients treated at the First Medical Center of the Chinese PLA General Hospital (PLAGH) from January 2012 to August 2018.
Who may be able to join
- Age ≥ 65 years;
- Patients undergoing surgeries not involving local anesthesia.
Who cannot join
- Patients undergoing neurosurgery or cardiac surgery;
- Patients with preoperative infections (including pneumonia, SSIs, UTIs, and bloodstream infections);
- Uncertain type of operation
Trial locations and contacts
1 site in 1 country.
China1 site
Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: Latent Class Analysis and Phenotypes Identification of Surgical Site Infection in Elderly Patients After Non-cardiac Surgery---Based on a Prediction Model Established by Two Centers Large Sample
This study utilizes Latent Class Analysis (LCA) to identify phenotypes of Surgical Site Infection (SSI) in elderly patients following non-cardiac surgery. By analyzing data from two large cohorts, the research establishes a predictive model that uncovers independent risk factors for SSI, including age, hyperlipidemia, and surgical characteristics. The model, with AUCs ranging from 0.753 to 0.791 across cohorts, offers a calibrated prediction of SSI risk. Furthermore, LCA delineates four distinct SSI subphenotypes, highlighting a critical subgroup with a higher infection rate. This subgroup presents a complex interplay of risk factors, indicating the need for tailored preventive strategies. The study's findings contribute to a nuanced understanding of SSI in elderly surgical patients and pave the way for more targeted infection control measures.
Read the detailed description
Backgrounds:
With the widespread use of prophylactic antibiotics during perioperative period and the continuous promotion of minimally invasive non-cardiac surgery type such as laparoscopic and thoracoscopic surgery, the incidence of superficial Surgical Site Infection (SSI) has been significantly reduced. Organ/deep SSI has become the dominant type of SSI. Currently, the classification of SSI is limited to the above location from shallow to deep, the epidemiological and clinical characteristics of SSI after non-cardiac surgery in elderly patients are still inadequately defined.
Objectives:
The investigators aimed to determine main risk factors for SSI after non-cardiac surgery among elderly patients in China and to further reveal the clinical attributes of those elderly patients afflicted with SSI.
Methods:
Potential risk factors for developing SSI were selected based on published data, clinical expertise, pathophysiological reasoning, and convenient considerations for future clinical applications. These SSI outcomes were rigorously calibrated by researchers complying with back-to-back principles following uniform diagnostic standards--European Perioperative Clinical Outcome (EPCO) definitions. According to the definitions, SSI in this study consists of three sites: superficial incision, deep incision, and organ/deep. The investigators define the occurrence of any of the above sites as SSI infection. Multivariable logistic regression analysis was used to identify risk factors for SSI. Data from population-based cohort of elderly patients undergoing non-cardiac and non-neurology surgery were used to derive the model. The risk prediction model was derived from the First Medical Center of the Chinese PLA General Hospital (January 2012 - August 2018). The investigators performed a nomogram, a complanation model based on the regression model with the graduated line segments as the main body. The discrimination was compared based on the AUC. The calibration was assessed by the calibration intercept and the slope. Decision curve analysis (DCA) was adopted to determine the nomogram's clinical usefulness and net benefit. Latent class analysis (LCA) was further used to explore the population features of SSI. LCA combines the latent variable theory with classified variables to explore the category latent variables behind statistically related classified explicit variables. Utilizing LCA, patients were classified into distinct cluster classifications, with each cluster's traits explained based on clinical factors. All continuous variables in the prediction model were treated as categorical variables before the LCA analysis. The number of categories was ascertained via the Bayesian information criterion (BIC). The lower BIC was also the elbow point which indicates better model fit. When determining the number of latent classes, clinical interpretations were taken into account. To demonstrate the combination of different risk factors in the prediction model, a chord chart and a characteristic data distribution map of subphenotypes were devised.
- Keywords
- the elderly, prediction model, surgical site infection, latent class analysis
- Medical subject headings
- Surgical Wound Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Elderly Patients Surgical Site Infection Phenotypes Identification
This study applies Latent Class Analysis to identify SSI phenotypes in elderly post-non-cardiac surgery patients, revealing four distinct subgroups with varying infection risks. The predictive model, validated across two cohorts, underscores the importance of tailored preventive strategies for high-risk subgroups, enhancing SSI management in elderly surgical patients.
Measured: January 2012 - August 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Jan 2023
- Primary completion30 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 42,532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weidong Mi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612177
- Sponsor's protocol ID
- PLAGH-AOC-L04
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latent Class Analysis and Phenotypes Identification of Surgical Site Infection in Elderly Patients After Non-cardiac Surgery---Based on a Prediction Model Established by Two Centers Large Sample
- ClinicalTrials.gov ID
- NCT06612177
- Acronym / sponsor ID
- PLAGH-AOC-L04
- Keywords
- the elderly, prediction model, surgical site infection, latent class analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42,532 participants (actual)
- Lead sponsor
- Weidong MiUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study utilizes Latent Class Analysis (LCA) to identify phenotypes of Surgical Site Infection (SSI) in elderly patients following non-cardiac surgery. By analyzing data from two large cohorts, the research establishes a predictive model that uncovers independent risk factors for SSI, including age, hyperlipidemia, and surgical characteristics. The model, with AUCs ranging from 0.753 to 0.791 across cohorts, offers a calibrated prediction of SSI risk. Furthermore, LCA delineates four distinct SSI subphenotypes, highlighting a critical subgroup with a higher infection rate. This subgroup presents a complex interplay of risk factors, indicating the need for tailored preventive strategies. The study's findings contribute to a nuanced understanding of SSI in elderly surgical patients and pave the way for more targeted infection control measures.
Detailed description
Backgrounds:
With the widespread use of prophylactic antibiotics during perioperative period and the continuous promotion of minimally invasive non-cardiac surgery type such as laparoscopic and thoracoscopic surgery, the incidence of superficial Surgical Site Infection (SSI) has been significantly reduced. Organ/deep SSI has become the dominant type of SSI. Currently, the classification of SSI is limited to the above location from shallow to deep, the epidemiological and clinical characteristics of SSI after non-cardiac surgery in elderly patients are still inadequately defined.
Objectives:
The investigators aimed to determine main risk factors for SSI after non-cardiac surgery among elderly patients in China and to further reveal the clinical attributes of those elderly patients afflicted with SSI.
Methods:
Potential risk factors for developing SSI were selected based on published data, clinical expertise, pathophysiological reasoning, and convenient considerations for future clinical applications. These SSI outcomes were rigorously calibrated by researchers complying with back-to-back principles following uniform diagnostic standards--European Perioperative Clinical Outcome (EPCO) definitions. According to the definitions, SSI in this study consists of three sites: superficial incision, deep incision, and organ/deep. The investigators define the occurrence of any of the above sites as SSI infection. Multivariable logistic regression analysis was used to identify risk factors for SSI. Data from population-based cohort of elderly patients undergoing non-cardiac and non-neurology surgery were used to derive the model. The risk prediction model was derived from the First Medical Center of the Chinese PLA General Hospital (January 2012 - August 2018). The investigators performed a nomogram, a complanation model based on the regression model with the graduated line segments as the main body. The discrimination was compared based on the AUC. The calibration was assessed by the calibration intercept and the slope. Decision curve analysis (DCA) was adopted to determine the nomogram's clinical usefulness and net benefit. Latent class analysis (LCA) was further used to explore the population features of SSI. LCA combines the latent variable theory with classified variables to explore the category latent variables behind statistically related classified explicit variables. Utilizing LCA, patients were classified into distinct cluster classifications, with each cluster's traits explained based on clinical factors. All continuous variables in the prediction model were treated as categorical variables before the LCA analysis. The number of categories was ascertained via the Bayesian information criterion (BIC). The lower BIC was also the elbow point which indicates better model fit. When determining the number of latent classes, clinical interpretations were taken into account. To demonstrate the combination of different risk factors in the prediction model, a chord chart and a characteristic data distribution map of subphenotypes were devised.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The Training set included 42,532 elderly patients treated at the First Medical Center of the Chinese PLA General Hospital (PLAGH) from January 2012 to August 2018.
Key inclusion criteria (2 listed)
- Age ≥ 65 years;
- Patients undergoing surgeries not involving local anesthesia.
Key exclusion criteria (3 listed)
- Patients undergoing neurosurgery or cardiac surgery;
- Patients with preoperative infections (including pneumonia, SSIs, UTIs, and bloodstream infections);
- Uncertain type of operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elderly Patients Surgical Site Infection Phenotypes Identification
Time frame: January 2012 - August 2018
This study applies Latent Class Analysis to identify SSI phenotypes in elderly post-non-cardiac surgery patients, revealing four distinct subgroups with varying infection risks. The predictive model, validated across two cohorts, underscores the importance of tailored preventive strategies for high-risk subgroups, enhancing SSI management in elderly surgical patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Infection and Geriatrics, run by Weidong Mi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elderly Patients Surgical Site Infection Phenotypes Identification (time frame: January 2012 - August 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.